The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.” As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”). Chapter III of the Directive sets out the new procedures for national marketing authorizations (“MAs”). This includes a purely national MA procedure granted in a single Member State … Read the rest
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The Supreme Court will review how employers must accommodate their employees’ religious practices, how courts should decide whether threatening statements are protected by the First Amendment, and whether a local government violated the Constitution when it confiscated and sold a $ 40,000 home based on the owner’s failure to pay $ 15,000 in property taxes.
Those issues are among a slew of new disputes that the justices added to their docket on Friday afternoon in an order list from … Read the rest
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The Supreme Court announced on Thursday afternoon that it will weigh in on what it means to commit identity theft. After holding their private conference a day early because Friday is a federal holiday, the justices released a one-sentence order list that added one new case to their merits docket for the 2022-23 term: Dubin v. United States.
The defendant in the case is David Dubin, who was convicted of Medicaid fraud. As the dispute comes to the … Read the rest
The Reagan-Udall Foundation has announced five members of an independent expert panel who will conduct an operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner, was named as chair of the panel last month.
Joining Henney are Francisco Diez-Gonzalez, James Jones, Barbara Kowalcyk, Shiriki Kumanyika, and John Taylor.
“This team brings the right combination of FDA and other government experience along with deep subject matter expertise and first-hand systems and operations knowledge,” said … Read the rest
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The Supreme Court on Tuesday morning added two cases — one involving the Bank Secrecy Act, the other involving the government’s power to dismiss fraud claims — to its 2022-23 docket. In a list of orders from the justices’ private conference last week, the justices also turned down – over a dissent from Justice Clarence Thomas that was joined by Justice Samuel Alito – a request from Ohio to reinstate the conviction and death sentence of an inmate who … Read the rest
We all know that it takes some “outside of the box thinking” to help improve the legal system in the United States, especially when it comes to Pro Se litigants. Courtroom5 CEO and co-founder Sonja Ebron does exactly that with her startup focused on guiding Pro Se litigants through complex court processes. Ed Walters, CEO and co-founder of Fastcase wants the legal industry to stop trying so hard to reinforce that “box.” Together, Ebron and Walters are creating a process … Read the rest
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The Supreme Court on Monday added two new cases, both involving the jurisdiction of federal district courts, to the merits docket for the 2022-23 term. And the justices called for the federal government’s views in two more cases, involving a school board’s responsibility for student-on-student sexual harassment and pleading requirements in cases brought under the False Claims Act.
In Securities and Exchange Commission v. Cochran, the justices agreed to decide whether federal district courts have the power to … Read the rest
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After adding five cases to its merits docket for the spring on Friday, the Supreme Court on Tuesday morning issued more orders from the justices’ private conference last week. As expected, the justices did not grant any new cases. Perhaps most notably, they once again did not act on a pair of petitions challenging the consideration of race in the undergraduate admissions process at Harvard University and the University of North Carolina, nor did they act on a petition … Read the rest